The present invention relates generally to endoscopes and relates more particularly to a transluminal endoscopic surgery kit.
Numerous medical procedures involve making an incision in body tissue and controlling any consequent bleeding. When performing these procedures, it is very important to minimize both tissue trauma during incision and the time required to stop internal bleeding. Minimally invasive procedures, such as those performed using endoscopy, are highly desirable because body tissue is usually traumatized less by these procedures than by more invasive conventional procedures.
In a typical endoscopic procedure, a patient is administered a mild sedative, and the distal end of an endoscope is inserted into the gastrointestinal tract through a natural orifice, such as the mouth or the anus, until the distal end of the endoscope is positioned near an area of interest within the GI tract. Next, an instrument suitable for use in performing a desired procedure on the area of interest is inserted into a working channel of the endoscope. An endoscopist then uses the instrument to perform the procedure on the area of interest. Once the procedure is complete, the instrument is withdrawn from the endoscope, and the endoscope is withdrawn from the patient.
An example of an endoscopic procedure of the type described above is disclosed in U.S. Pat. Nos. 6,238,335, 6,251,063, 6,251,064 and 6,695,764, all of which are incorporated herein by reference. More specifically, these patents disclose an endoscopic procedure for treating gastroesophageal reflux disease (GERD). GERD is a condition in which heartburn is severe enough or frequent enough to disrupt daily activities and/or sleep. Heartburn occurs when stomach fluids and acids escape from the stomach and enter into the esophagus, irritating the esophagus. Normally, a muscular ring called the lower esophageal sphincter (LES) acts as a valve between the esophagus and the stomach to allow food to pass from the esophagus into the stomach while keeping stomach fluids and acids from escaping from the stomach into the esophagus. In those instances in which the LES fails to keep stomach fluids and acids in the stomach, heartburn occurs. In some people who have GERD, the LES relaxes more than it should and/or at the wrong times. In addition to causing frequent and/or severe heartburn, GERD can cause other health problems. For example, the fluids and acids that reflux into the esophagus can lead to inflammation of the esophagus (esophagitis) or ulcers. In severe cases, this damage can scar the esophageal lining and narrow it, causing a stricture which may make it hard or painful for the patient to swallow. In certain cases, this may lead to a condition called Barrett's esophagus, where the lining of the esophagus changes and may over time lead to cancer of the esophagus.
The endoscopic procedure described in the above patents involves inserting an endoscope down through the patient's mouth and into the esophagus in proximity to the LES. Then, the distal end of a device commonly referred to as “an injection needle” is inserted through a working channel of the endoscope until a needle at the distal end of the injection needle is inserted into the muscle of the LES. Then, a special solution is dispensed through the injection needle and into the muscle of the LES. The solution includes a biocompatible polymer that forms a soft, spongy, permanent implant in the sphincter muscle that helps the LES to keep stomach fluids and acids from backing up into the esophagus.
Typically, an injection needle of the type referred to above comprises a hollow needle, a flexible inner catheter, a flexible outer catheter, an inner hub and an outer hub. The proximal end of the hollow needle is typically fixedly mounted within the distal end of the flexible inner catheter. The inner hub is typically fixedly mounted on the proximal end of the inner catheter and is adapted to convey fluids to the inner catheter from a needleless syringe or the like. The inner catheter and the hollow needle are typically slidably mounted within the outer catheter so that one may extend the hollow needle out of the distal end of the outer catheter when one wishes to make an injection and retract the hollow needle into the outer catheter when not making an injection. The outer hub is typically fixedly mounted on the proximal end of the outer catheter and is adapted to engage the inner hub so as to limit the distal movement of the needle and the inner catheter relative to the outer catheter. Examples of injection needles are disclosed in the following patents, all of which are incorporated herein by reference: U.S. Pat. Nos. 6,770,053; 6,585,694; 6,423,034; 6,401,718; 6,336,915; 5,785,689; 4,946,442; and 4,668,226.
A newly emerging area of medicine is NOTES, i.e., Natural Orifice Transluminal Endoscopic Surgery. In NOTES, endoscopic procedures are performed in the abdominal cavity using an endoscope that has been inserted through a natural orifice and is then passed through an incision in the gastrointestinal tract and into the abdominal cavity. More specifically, the NOTES procedure typically involves inserting the distal end of an endoscope through a natural orifice, such as the mouth or anus, and into the gastrointestinal tract, creating an opening at a desired location within the gastrointestinal tract (e.g., the stomach, the esophagus, the large intestine, the small intestine), dilating the opening, and passing the endoscope through the dilated opening into the abdominal cavity. The distal end of the endoscope may then be advanced to a target area within the cavity, and a surgical procedure may then be performed on the target area using instruments delivered by the endoscope. Examples of procedures for which NOTES may be suitable include appendectomies and cholecystectomies. Other natural orifices for which NOTES may be suitable include the vagina and the urethra.